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Group Exercise Program Supported By Audiovisual Media During Hemodialysis

Evaluating The Feasibility And Safety Of A Group Exercise Program Supported By Audiovisual Media During Hemodialysis (GrExID)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06660160
Acronym
GrExID
Enrollment
45
Registered
2024-10-28
Start date
2024-10-28
Completion date
2026-05-30
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Functional Capacity, Hemodialysis, Muscle Strength Dynamometer, Physical Activity Level, Sarcopenia

Keywords

Chronic Kidney Failure, Hemodialysis, Exercise, Sarcopenia, Muscle strength, Functional capacity, Dynamometer, Physical activity level

Brief summary

People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Exercise programs during HD are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. Therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during HD sessions. Additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.

Detailed description

A 4-week randomized experimental study will be conducted, using an exercise protocol during HD, broadcast simultaneously on television. The frequency of exercise completion, reasons for non-completion, adverse events, as well as sarcopenia, muscle strength, muscle characteristics through ultrasound and electrical bioimpedance, and physical activity levels will be evaluated.

Interventions

OTHERExercise program supported by audiovisual media

The intervention group will perform the group exercise protocol during HD sessions. The videos with the exercises will be broadcast on all televisions simultaneously, so that the volunteers perform the exercises along with the person in the video. * The first level of difficulty includes 5 exercises for the lower limbs and 3 exercises for the upper limbs. One set of 10 repetitions will be performed for each exercise per session. * The second level includes 3 exercises for the lower limbs and 2 exercises for the upper limbs. These consist of proprioceptive neuromuscular facilitation diagonals for both the lower and upper limbs. One set of 10 repetitions will be performed for each exercise, once per week, for 3 weeks. * The third level includes 8 combined lower and upper limb exercises performed simultaneously. One set of 20 repetitions will be performed for each exercise. Exercises will be performed 3 times per week over a 4-week period, for a total of 12 planned exercise sessions.

Sponsors

Cardenal Herrera University
Lead SponsorOTHER
B.Braun Avitum AG
CollaboratorINDUSTRY
Universidade Federal de Juiz de Fora
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Over 18 years old of both sexes; * Undergoing HD for at least three months in three sessions per week, four hours, totaling 12 hours per week.

Exclusion criteria

* Lower limb amputations; * Neurological, musculoskeletal, or osteoarticular disorders; * Severe and unstable comorbidities; * Undergoing high doses of corticosteroids (\>30 mg/day); * Inability to understand the measurement methods used.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and Safety AssessmentFrom start to finish of intervention (4 weeks)Feasibility will be assessed through adherence rate (number of sessiones performed out of sessions offered).

Secondary

MeasureTime frameDescription
Sarcopenia Risk AssessmentIt will be applied before and after the 4 weeks of intervention.The risk of sarcopenia will be evaluated using the SARC-F (Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls )questionnaire. Score ranges from 0 a 10, higher scores mean higher risc of sarcopenia.
Muscle Strength AssessmentIt will be applied before and after the 4 weeks of interventionHandgrip strength
Muscle CharacteristicsIt will be applied before and after the 4 weeks of interventionThe quantity and quality of muscle mass will be evaluated by the cross-sectional area of the rectus femoris muscle, measured by muscle ultrasound.
Physical Activity Level AssessmentIt will be applied before and after the 4 weeks of intervention.The level of physical activity will be evaluated using the HAP questionnaire (Average Activity Score AAS).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026